Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

NCT ID: NCT04580784

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2024-05-31

Brief Summary

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The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.

Detailed Description

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Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.

Conditions

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Breast Cancer Radiotherapy Side Effect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypofractionation

Hypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions.

Group Type EXPERIMENTAL

Weekly hypofractionation for early breast cancer

Intervention Type RADIATION

Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks

Interventions

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Weekly hypofractionation for early breast cancer

Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Histologically proven diagnosis of invasive breast adenocarcinoma.
2. Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery).
3. No macroscopic evidence of distant metastases at diagnosis.

Exclusion Criteria

1. Prior radiation to the thoracic region.
2. Pregnancy.
3. Patients with synchronous or prior malignancy.
4. Positive surgical margins.
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role collaborator

Mona Salem

OTHER

Sponsor Role lead

Responsible Party

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Mona Salem

Assistant Lecturer of clinical oncology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mona Salem, MSc

Role: PRINCIPAL_INVESTIGATOR

Kasr El AiniH

Locations

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Kasr El AiniH

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mona M Salem, MSc

Role: CONTACT

00201007731412

Facility Contacts

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Dean's office

Role: primary

002025729584

Other Identifiers

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FAST feasibility in CU

Identifier Type: -

Identifier Source: org_study_id

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